SKINTACT PD50-F4C

GUDID 29005531000432

Pre-wired ECG Electrode

Leonhard Lang GmbH

Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode Neonatal electrocardiographic electrode

• Primary Device ID: 29005531000432
• NIH Device Record Key: 773338c0-fc54-4d8f-a1d0-ea6c4602e1e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKINTACT
• Version Model Number: PD50-F4C
• Catalog Number: PD50-F4C
• Company DUNS: 302846407
• Company Name: Leonhard Lang GmbH
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09005531000438 [Unit of Use]
GS1	19005531000435 [Primary]
GS1	29005531000432 [Package]; Contains: 19005531000435; Package: Box [50 Units]; In Commercial Distribution

FDA Product Code

• DRX: Electrode, Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [SKINTACT]

• 39005531595522: ECG Electrodes
• 39005531595171: ECG Electrodes
• 39005531593337: Neutral Electrode
• 29005531593248: Neutral Electrode
• 39005531592989: Neutral Electrode
• 39005531592033: ECG Electrodes
• 39005531592026: ECG Electrodes
• 39005531591999: ECG Electrodes
• 39005531591548: Neutral Electrode
• 29005531591527: Neutral Electrode
• 39005531590848: ECG Electrodes
• 29005531589883: ECG Electrodes
• 39005531588630: Resting ECG Electrodes
• 39005531587633: ECG Electrodes
• 39005531586599: Resting ECG Electrodes
• 39005531586568: Resting ECG Electrodes
• 29005531586431: ECG Electrodes
• 39005531584533: ECG Electrodes
• 29005531580521: ECG Electrodes
• 29005531580514: ECG Electrodes
• 29005531580477: ECG Electrodes
• 29005531580460: ECG Electrodes
• 29005531580316: ECG Electrodes
• 29005531580293: ECG Electrodes
• 29005531580286: ECG Electrodes
• 39005531580269: ECG Electrodes
• 29005531580088: ECG Electrodes
• 29005531580033: ECG Electrodes
• 39005531580023: ECG Electrodes
• 39005531506498: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
• 39005531506443: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
• 39005531506436: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
• 39005531506382: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
• 39005531506061: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
• 29005531505838: ECG Electrodes
• 29005531505753: ECG Electrodes
• 39005531505484: ECG Electrodes
• 39005531503749: ECG Electrodes
• 39005531502919: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
• 39005531502452: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
• 39005531501165: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
• 39005531501134: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
• 39005531500281: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
• 39005531500250: Multifunction electrode for defibrillation, pacing, cardioversion, and monitoring
• 39005531000576: FS-WA10C /5
• 29005531000395: W-130C /3
• 29005531000104: Accessory for ECG Electrodes
• 19005531000084: Accessory for ECG Electrodes
• 29005531000012: ECG Electrodes
• 29005531000432: Pre-wired ECG Electrode